Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation

NCT06399666 | Recruiting

• 1 other identifier: Dnr 2023-02252-01
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 2

Brief Summary

Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value. This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \>18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG. An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.

Conditions

Atrial Fibrillation; Inflammation; Genetic Predisposition to Disease

Outcome Measures

Primary Outcomes (1)

• Recurrence of AF

  Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation

  During follow-up (post ECV, day 7, 30, 90, and 180)

Secondary Outcomes (1)

• Fluctuations of biomarkers and gene expression during follow-up

  During follow-up (post ECV, day 7, 30, 90, and 180)

Study Arms (1)

Prospective cohort

Prospective cohort measuring the previously described biomarkers.

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.

You may qualify if:

• Persistent atrial fibrillation (ICD-10 I48.1)
• Age over 18 years

You may not qualify if:

• Autoimmune disease
• Inflammatory diseases
• Acute or chronic liver dysfunction
• Ongoing infectious diseases
• Thyroid disorders
• Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)

Sponsors & Collaborators

• Vrinnevi Hospital: lead
• Ryhov County Hospital: collaborator

Study Sites (2)

Medical department

Jönköping, Småland, Sweden

RECRUITING

Cardiology Clinic

Norrköping, Östergötland County, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Atrial Fibrillation; Inflammation; Genetic Predisposition to Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jakob Hytting, MD

CONTACT

+46 + 707679724; jakob.hytting@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Department of Cardiology, Principal Investigator, Doctoral Candidate

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: October 30, 2023
• Primary Completion: June 1, 2025
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)